Abstract 677P
Background
Renal cell carcinoma accounts for 90% of all kidney cancers. Five-year survival rates are 80% to 90% among stage I or II patients,only 12% in metastatic disease. Treatment of advanced renal cell carcinoma (aRCC) is challenging. Recent evidence shows immunotherapy improve the prognosis of these patients. We aim to evaluate the efficacy and safety of immunotherapy versus sunitinib as first line treatment in patients with favourable risk aRCC.
Methods
We conducted a systematic search in PubMed, Ovid MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. The GRADE approach was used to assess the quality of evidence. Survival hazard ratios were extracted for analysis in the entire population and the favourable risk subgroup (IMDC).
Results
A total of six randomised controlled trials with a total of 5121 patients were included in quantitative synthesis. The studies included different immunotherapy regimens. All clinical trials reported OS and PFS data showing an overall advantage of the immunotherapy regimen vs sunitinib for these outcomes (OS: HR = 0·71, 95% CI = 0·61 - 0·84; PFS: HR = 0·64, 95% CI = 0·51 - 0·82). There was no difference for survival between treatment arms in the favorable risk subgroup analysis (OS: HR = 1·07, 95% CI = 0·81 - 1·41; PFS: HR = 0·74, 95% CI = 0·46 - 1·19) (see the table). The safety profile reported is consistent with previous reports. Table: 677P
| Study | Intervention | OS HR (95% CI) | PFS HR (95% CI) |
| CheckMate 9ER | Nivolumab + Cabozantinib | 0.84 (0.35, 1.97) | 0.62 (0.38, 1.01) |
| CheckMate214 | Nivolumab + Ipilimumab | 1.19 (0.77, 1.85) | 1.65 (1.16, 2.35) |
| JAVELIN Renal 101 | Avelumab + Axitinib | 0.81 (0.34, 1.96) | 0.63 (0.40, 0.99) |
| Keynote 426 | Pembrolizumab + Axitinib | 1.06 (0.60, 1.86) | 0.79 (0.57, 1.09) |
| CLEAR | Lenvatinib + Pembrolizumab | 1.15 (0.55, 2.40) | 0.41 (0.28, 0.62) |
| Overall | 1.07 (0.81, 1.41) | 0.74 (0.46, 1.19) | |
| I-squared | 0.0% | 86.3% |
Conclusions
Immunotherapy as first-line treatment improves overall survival and progression-free survival for patients with advanced renal cell carcinoma. In the favourable risk subgroup, this advantage is not confirmed yet. More prospective trials with a larger sample size and longer-term follow-up are needed to identify an advantage in OS and PFS.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
R. Manneh Kopp.
Funding
Grupo de Oncología Genitourinaria de Colombia.
Disclosure
R. Manneh Kopp: Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: MSD; Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: BMS; Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: Pfizer. M. Lema Medina: Financial Interests, Personal, Invited Speaker, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker, Advisory Board: Novartis. G. De Velasco: Financial Interests, Personal, Invited Speaker, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker, Advisory Board: Novartis. D. Castellano Gauna: Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: MSD; Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: BMS; Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: Pfizer; Financial Interests, Personal and Institutional, Invited Speaker, Advisory Board: Novartis. All other authors have declared no conflicts of interest.